Name: Predicase
Price: 199 USD

K-number	K152069
Device name	Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
Applicant	Navilyst Medical, Inc.
Product code	FGE
Device class	Class II
Decision date	Sep 24, 2015
Decision	Substantially Equivalent
Regulation	876.5010

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Source

View the full FDA submission: accessdata.fda.gov

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Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter

Everything you need for a 510(k) submission. Nothing you don't.